Cleared Special

K992411 - ESCORT II+ 400 SERIES (ESCORT PRISM) MO...

K992411 is an FDA 510(k) clearance for ESCORT II+ 400 SERIES (ESCORT PRISM) MO..., manufactured by Medical Data Electronics. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Special 510(k) pathway after a 29-day FDA review.

K992411 · Medical Data Electronics · Cardiovascular device
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Aug 1999
Decision
29d
Days
Class 2
Risk

K992411 is an FDA 510(k) clearance for the ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on August 18, 1999 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Data Electronics devices

FDA 510(k) Submission Details - K992411

510(k) Number K992411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1999
Decision Date August 18, 1999
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 167
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K992411.
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
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K992413 · Medical Data Electronics · Aug 1999
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K973918 · Nihon Kohden America, Inc. · Jan 1998